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Coronary Syndrome, Acute, Non-ST Elevation, High Risk PatientsNSTE-ACSMTNCT06279663

Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

A study testing Revascularization in people with Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients, run by Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me at 2 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Revascularization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
2 sitesRussia
Study dates
29 Feb 2024to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Acute coronary syndrome without ST segment elevation of high risk: unstable angina pectoris or myocardial infarction requiring revascularization within 24 hours based on the risk of an unfavorable outcome (increase or decrease in the concentration of cardiac troponin in the blood that meet the criteria of MI; dynamic ST segment displacement or changes in T; risk on the GRACE scale >140 points)
  • The patient is suitable for both CABG and PCI, confirmed by an interventional cardiologist and surgeon (multivessel lesion with a Sintax score of 23-32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery).
  • Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of > 2.5 mm, that is, residual coronary artery stenosis of no more than 60%).
  • Signed informed consent
  • Age over 18 years.

Who cannot join

  • Myocardial infarction with ST segment elevation
  • Stable angina pectoris
  • Patients with OSN Killip II-IV class
  • Patients required an immediate PCI procedure (e.g. electrical instability)
  • A history of hemorrhagic stroke one year before the procedure
  • Ischemic stroke or TIA in the last 6 weeks
Show all 12Show fewer
  • The final stage of chronic renal failure requiring dialysis.
  • Preliminary PCI for any other coronary artery lesion within 1 year prior to randomization.
  • Pre-CABG at any time prior to randomization.
  • The need for concomitant cardiac surgery, except for CABG (for example, valve surgery, aortic repair, etc.). Patients who require additional surgery (cardiological or extra-cardiac) for 1 year.
  • Non-cardiac concomitant diseases with a life expectancy of less than 1 year (for example, oncological diseases).
  • 13. The left ventricular ejection fraction is less than 40%. 14. Severe degree of COPD

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Russia2 sites, 2 recruiting

  • Anton

    Novosibirsk, Novosibirsk Obl, 630055

    Anton Obedinskiy, 1, +73833476099 ext. 1, a_obedinskij@meshalkin.ru

    Recruiting

  • Anton

    Novosibirsk, Rechkunovskaya Str., 630055

    Anton Obedinskiy, 89139322885, a_obedinskij@meshalkin.ru

    Recruiting

Other trials in Russia

About this study

Official title: A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of > 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG.

Being tested
Revascularization
Medical subject headings
Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RevascularizationProcedure or surgery

    revascularization

Study groups in NCT06279663
Study groupRoleWhat they receive
PCIActive comparatorcomplete revascularization
Receives: Procedure: Revascularization
CABGActive comparatorNot described
Receives: Procedure: Revascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death from any cause

    a fatal outcome due to any cause or disease

    Measured: 1 year

  2. Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)

    Death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization.

    Measured: 1 year

  3. target LDL level

    Achieved target LDL level

    Measured: 1 year

Secondary outcomes (7)

  1. Myocardial infarction

    Myocardial infarction (Fourth universal definition of myocardial infarction (2018))

    Measured: 1 year

  2. Stroke

    clinically verified acute cerebrovascular accident of any etiology (hemorrhagic or ischemic)

    Measured: 1 year

  3. Repeated unplanned myocardial revascularization

    any type of repeated myocardial revascularization by endovascular or cardiac surgery performed in the time period after index revascularization;

    Measured: 1 year

  4. Duration of the hospital period

    the number of bed days that the patient spent in the clinic in connection with an index event and/or complications arising from the underlying, concomitant diseases, as well as in connection with the treatment.

    Measured: 1 year

  5. Intra/perioperative complications

    Any intra/perioperative complications (MI, Stroke, hemorrhagic complication, )

    Measured: 1 year

  6. Significant hemorrhagic complications (grade 3 or more on the BARC scale)

    any bleeding that occurred during or after the index revascularization of the myocardium, leading to a clinically significant decrease in hemoglobin levels, requiring hemotransfusion and/or surgical methods of hemostasis, artery dissection, shunt thrombosis, and other

    Measured: 1 year

  7. Questionnaire

    SF-36 Quality of Life Questionnaire and Rose Questionn

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start29 Feb 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279663
Sponsor's protocol ID
NSTE-ACS Multivessel Trial
Acronym
NSTE-ACSMT
Status last verified
Mar 2024
First submitted
15 Feb 2024
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Revascularization in people with Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients, run by Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death from any cause (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06279663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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